Trial Outcomes & Findings for Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine (NCT NCT01469637)
NCT ID: NCT01469637
Last Updated: 2021-07-13
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Assessed over a 24-hour period starting post-dose on day 4
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
Sulfamethoxazole + MMX Placebo First
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine First
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
|
|---|---|---|
|
First Intervention
STARTED
|
22
|
22
|
|
First Intervention
COMPLETED
|
22
|
21
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
22
|
21
|
|
Second Intervention
COMPLETED
|
21
|
21
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sulfamethoxazole + MMX Placebo First
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine First
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
|
|---|---|---|
|
First Intervention
Unacceptable behavior
|
0
|
1
|
|
Second Intervention
Incarcerated
|
1
|
0
|
Baseline Characteristics
Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Baseline characteristics by cohort
| Measure |
Sulfamethoxazole + MMX Placebo First
n=22 Participants
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine First
n=22 Participants
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Age, Customized
18 to 55 years of age
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.
Outcome measures
| Measure |
Sulfamethoxazole + MMX Placebo
n=43 Participants
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine
n=43 Participants
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole
|
786 h*ug/ml
Standard Deviation 169
|
909 h*ug/ml
Standard Deviation 198
|
PRIMARY outcome
Timeframe: Assessed over a 24-hour period starting post-dose on day 4Population: Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
Sulfamethoxazole + MMX Placebo
n=43 Participants
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine
n=43 Participants
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
|
|---|---|---|
|
Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole
|
89.1 ug/ml
Standard Deviation 16.3
|
100 ug/ml
Standard Deviation 20.2
|
Adverse Events
Sulfamethoxazole + MMX Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sulfamethoxazole + MMX Mesalazine/Mesalamine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sulfamethoxazole + MMX Placebo
n=43 participants at risk
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
|
Sulfamethoxazole + MMX Mesalazine/Mesalamine
n=44 participants at risk
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/43 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/43 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1
|
0.00%
0/44
|
|
Infections and infestations
Laryngitis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • Number of events 4
|
11.4%
5/44 • Number of events 5
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/43
|
2.3%
1/44 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER